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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K210820
Device Name EAGLE EDGE AXR90 and AXR120
Applicant
Alliage S/A Industrias Medico Odontológica
Rod. Abrão Assed, Km 53+450m
Recreio Anhanguera,  BR 14097-500
Applicant Contact Daniel Camargo
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1750
Classification Product Code
OAS  
Date Received03/19/2021
Decision Date 08/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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